YY/T 0128-2023Protective devices against diagnostic medical X-radiation - Devices and appliances (English PDF)

1 Scope

YY/T 0128 covers the shielding used against diagnostic X-rays: the aprons, thyroid collars, gonad shields, gloves, screens and mobile barriers that protect patients and staff in radiology, cardiology and theatre. It sets the requirements such devices have to meet and the test methods that verify them, covering the lead equivalence they provide, the uniformity and integrity of the shielding material, the coverage the design offers and the marking that tells the user what protection they are wearing. Protective equipment ages invisibly, since a crack inside an apron leaves no external trace, which is why the standard specifies how attenuation is verified rather than assumed. For a manufacturer or a hospital radiation safety officer in China, this is the document conformity and periodic testing refer to.

This document specifies the requirements and inspection methods for the protective devices and tools against diagnostic medical X-radiation (hereinafter referred to as protective devices). This document is applicable to protective devices provided to users to shield or attenuate medical diagnostic X-ray radiation. This document does not apply to wearable medical diagnostic X-ray radiation protective supplies.

2 Normative References

The contents of the following documents constitute indispensable clauses of this document through normative references in the text. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document.

GB 9706.1-2020 Medical Electrical Equipment - Part

3 Terms and Definitions

The terms and definitions defined in GB 9706.1-2020, GB 9706.103, GB 9706.243, YY/T 0292.1-2020 and IEC/TR 60788, and the following are applicable to this document.

3.1 x-ray attenuation material A uniformly distributed material mainly composed of one or more elements with an atomic number higher than 47.

3.2 lead attenuation material A uniformly distributed material mainly composed of lead element, and does not contain other elements with an atomic number higher than 47.

3.6 effective shielding area The area formed by the X-ray attenuation material with a lead equivalent value reaching a specified lead equivalent class.

3.7 protective shield A constituent unit of the protective device that is made of hard X-ray attenuation material and provides protection to the users.

3.8 protective curtain A constituent unit in protective device made of an inner layer of soft X-ray attenuation material and an outer layer of waterproof knitted fabric or other waterproof soft materials, which provides protection to the users.

3.12 table mounted type A description of the functional characteristic of a protective device capable of being fixed at the bedside where a fluoroscopy-guided interventional operation equipment performs by its own connector.

4 Requirements

4.1 Materials and Composition The key materials and main components constituting the protective device.

4.2 Structure and Basic Mechanical Functions The structure and basic mechanical functions of the protective device.

5 Inspection Methods

5.1 Materials and Composition Conduct visual inspection of the protective device and check the bill of materials, which shall comply with the stipulations of 4.1.

5.2 Structure and Basic Mechanical Functions Conduct the inspection through visual inspection and / or by means of the following gauges or methods.